(12) United States Patent
`Us 7,449,184 132
`(10) Patent No.:
`Allison et al.
`(45) Date of Patent:
`Nov. 11, 2008
`
`USOO7449184B2
`
`(54) FIXED DOSING OF HER ANTIBODIES
`
`(75)
`
`Inventors: David E.Allison, San Mateo, CA (US);
`Rene Bruno, Marseilles (FR);
`Jian-Feng Lu, Foster City, CA (US);
`Chee M. Ng San Mateo CA (US)
`’
`’
`(73) Assignee: Genentech, Inc., South San Francisco,
`CA (US)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 121 days.
`
`(21) Appl. No.: 11/1543091
`
`(22)
`
`(65)
`
`Filed:
`
`Jun. 153 2005
`.
`.
`.
`Pmr Pubhcatlon Data
`US 2006/0165702 A1
`Jul. 27, 2006
`
`Related US. Application Data
`
`(60) Provisional application No. 60/645,697, filed on Jan.
`21, 2005.
`
`(51)
`
`Int. Cl.
`(2006.01)
`A61K 39/365
`(2006.01)
`C07K 16/30
`(52) us. Cl.
`.............. 424/1381; 424/1301; 424/141.1;
`424/143.1; 530/3871; 530/3881; 530/3888;
`530/38885; 514/2
`
`(58) Field of .Class1ficatlon Search ...............: ....... None
`See app11cat10n file for complete search hlstory.
`
`(56)
`
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`(commued)
`OTHER PUBLICATIONS
`
`Animal Dosage “Dose Calculator”, p. 1.*
`.
`(Commued)
`Primary ExamineriLarry R. Helms
`.
`.
`Asszslanl ExammeriLaura B Goddard
`(74) Attorney, Agent, or Firm7Wendy M. Lee
`
`(57)
`
`ABSTRACT
`
`.
`.
`.
`.
`The present mventlon concerns fixed dosmg of HER ant1bod-
`1655511011 as PeITUZUmah
`
`32 Claims, 18 Drawing Sheets
`
`Mylan V. Janssen (IPR2020-00440) EX. 1014 p. 001
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1014 p. 001
`
`

`

`US 7,449,184 B2
`
`Page 2
`
`US. PATENT DOCUMENTS
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`W0
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`W0
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`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`
`W0 87/07646 A2
`W0 89/ 10412 A1
`W0 91/02062 A2
`W0 91/05264 A1
`W0 93/03741 A1
`W0 93/12220 A1
`W0 93/16185 A2
`W0 93/21232 A1
`W0 93/21319 A1
`W0 94/00136 A1
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`W0 01/53354 A2
`W0 01/56604 A1
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`W0 01/76586 A1
`W001/76630 A1
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`
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`8/1993
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`6/1996
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`1/1997
`6/1997
`10/1997
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`5/1998
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`10/1998
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`9/1999
`11/1999
`2/2000
`10/2000
`10/2000
`11/2000
`12/2000
`1/2001
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`
`Mylan V. Janssen (IPR2020-00440) EX. 1014 p. 002
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1014 p. 002
`
`

`

`US 7,449,184 132
`
`Page 3
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`W0
`W0
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`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`
`W0 02/055106 A2
`W0 02/070008 A1
`W0 02/087619 A1
`W0 02/089842 A1
`W0 03/006509 A2
`W0 03/012072 A2
`W0 03/028638 A2
`W0 03/041736 A2
`W0 03/086467 A1
`W0 03/087131 A2
`W0 04/000094 A2
`WO 2004/008099 A2
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`Mylan v. Janssen (IPR2020-00440) Ex. 1014 p. 003
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1014 p. 003
`
`

`

`US 7,449,184 132
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`* cited by examiner
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1014 p. 005
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1014 p. 005
`
`

`

`U.S. Patent
`
`Nov. 11, 2008
`
`Sheet 1 of 18
`
`US 7,449,184 B2
`
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`
`Mylan v. Janssen (IPR2020-00440) Ex. 1014 p. 006
`
`
`

`

`US. Patent
`
`Nov. 11,2008
`
`Sheet 2 of 18
`
`US 7,449,184 B2
`
`VARIABLE LIGHT
`
`10
`
`20
`
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`
`40
`
`DTVMTQSHKIMSTSVGDRVSITC [KASQDVSIGVA] WYQQRP
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`DIQMTQSPSSLSASVGDRVTITC [RASQSISNYLA] WYQQKP
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`574
`
`50
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`60
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`70
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`80
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`574
`
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`FIG._2A
`
`VARIABLE HEAVY
`
`10
`
`20
`
`30
`
`40
`
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`
`574